Back to resultsEffect of Massage Treatment in Temporomandibular Joint (TMD)
Primary Purpose
Massage Therapy, Temporomandibular Disorder
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Massage therapy
non-effective treatment
Sponsored by
About this trial
This is an interventional treatment trial for Massage Therapy focused on measuring Massage
Eligibility Criteria
Inclusion Criteria:
- Temporomandibular disorder-positive RDC/TMD examination for groups RDC/TMD Ia and RDC/TMD Ib,
- Patient agreement to participate in the experimental study.
Exclusion Criteria:
- RDC/TMD II and RDC/TMDIII,
- Drug and/or removable partial or total prosthesis wearers,
- Being submitted to any type of physiotherapeutic treatment,
- Incomplete dentition,
- History of systemic diseases as diabetes or arthritis,
- The occurrence of facial trauma,
- Refusal to assume responsibility with this research.
Sites / Locations
- Istanbul university,Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
Test
Placebo
Control
Arm Description
Experimental group which employed with massage treatment
Placebo group which employed with non-effective treatment
no treatment
Outcomes
Primary Outcome Measures
Pain- Visual Analog Scale
Self-reported pain values. High scores for pain mean worse outcome for the study.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04132726
Brief Title
Effect of Massage Treatment in Temporomandibular Joint
Acronym
TMD
Official Title
Effect of Massage Treatment in Patients With Temporomandibular Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
February 23, 2019 (Actual)
Study Completion Date
October 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Temporomandibular disorders (TMD) have multiple and broad clinical effects on orofacial structures and are often diagnosed in patients with a prevalence of between 5% and 12%. Among treatment options, massage therapy is one of the common therapeutic procedures and allows interesting clinical outcomes by reducing TMD symptoms successfully. However, there has been no attempt to validate this knowledge. Thus, the aim of this study is to evaluate the effect of massage and its properties in patients with TMD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Massage Therapy, Temporomandibular Disorder
Keywords
Massage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test
Arm Type
Experimental
Arm Description
Experimental group which employed with massage treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo group which employed with non-effective treatment
Arm Title
Control
Arm Type
No Intervention
Arm Description
no treatment
Intervention Type
Other
Intervention Name(s)
Massage therapy
Intervention Description
Massage therapy performed by a physiotherapist
Intervention Type
Other
Intervention Name(s)
non-effective treatment
Intervention Description
non-effective treatment
Primary Outcome Measure Information:
Title
Pain- Visual Analog Scale
Description
Self-reported pain values. High scores for pain mean worse outcome for the study.
Time Frame
12 weeks-14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Temporomandibular disorder-positive RDC/TMD examination for groups RDC/TMD Ia and RDC/TMD Ib,
Patient agreement to participate in the experimental study.
Exclusion Criteria:
RDC/TMD II and RDC/TMDIII,
Drug and/or removable partial or total prosthesis wearers,
Being submitted to any type of physiotherapeutic treatment,
Incomplete dentition,
History of systemic diseases as diabetes or arthritis,
The occurrence of facial trauma,
Refusal to assume responsibility with this research.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merve Benli, Dr.
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul university,Faculty of Dentistry
City
Fatih
ZIP/Postal Code
34452
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19089025
Citation
Capellini VK, de Souza GS, de Faria CR. Massage therapy in the management of myogenic TMD: a pilot study. J Appl Oral Sci. 2006 Jan;14(1):21-6. doi: 10.1590/s1678-77572006000100005.
Results Reference
result
Learn more about this trial
Effect of Massage Treatment in Temporomandibular Joint
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